© 2006 Betterchem.com
March 15, 1988
I. GENERAL INFORMATION:
||Anthony Products Co.
5600 Peck Rd.
Arcadia, CA 91006
||Oxytetracycline Hydrochloride Injection, 50 mg and 100
|| Over-the-counter; Prescription
II. INDICATIONS FOR USE
Oxytetracycline HCl (50 mg and 100 mg) is intended for use in the treatment of the
following diseases in beef cattle and non-lactating dairy cattle when due to
In cattle, Oxytetracycline (50 mg and 100 mg) is indicated in the treatment of
pneumonia and shipping fever complex associated with Pasteurella spp. and
Hemophilus spp.; foot-rot and diphtheria caused by Fusobacterium
necrophorum;bacterial enteritis (scours) caused by Escherichia coli;
wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by
Leptospira pomona; and wound infections and acute metritis caused by strains of
staphylococci and streptococci organisms sensitive to oxytetracycline.
If the product contains the statement "Federal law restricts this drug to use
by or on the order of a licensed veterinarian," it may contain additional
directions for use in beef cattle and non-lactating dairy cattle for the
treatment of anaplasmosis caused by Anaplasma marginale and anthrax caused by
|| DOSAGE FORM
||Oxytetracycline HCl Injection (50 mg/ml and 100 mg/ml) is
available in 500 ml and 100 ml multidose vials containing 50 mg or 100
mg Oxytetracycline Hydrochloride per milliliter.
||ROUTE OF ADMINISTRATION
||Oxytetracycline Injection (50 mg/ml and 100 mg/ml) is administered
||The intravenous injection of 3 to 5 mg of Oxytetracycline
HCl per pound of body weight per day is the recommended dosage.
IV. ANIMAL SAFETY AND EFFECTIVENESS
An in-vitro equivalence of biological activity was conducted using
the microbiological method of potency testing as described in USP XXI and
comparing this biological activity with that of the Pfizer product for both
the 50 mg/ml and the 100 mg/ml products. The pioneer NAS/NRC/DESI product
(Pfizer) is cited in 21 CFR 522.1662a(c)(1). These conditions are NAS/NRC/DESI
reviewed and deemed safe and effective. Applications for these uses need not
include effectiveness data as specified by 21 CFR 514.111. However, satisfactory
bioequivalency data were submitted in support of this approval. The Anthony
and Pfizer 50 mg/ml products were tested and found to contain 50.4 - 53.8
and 52.4 -55.5 mg/ml oxytetracycline HCl, respectively. The 100 mg/ml generic
and Pfizer products were assayed and found to contain 100.5 - 105.5 and 108.3
and 113.4 mg/ml of oxytetracycline HCl, respectively. This data is satisfactory
and meets our requirements for the establishment of bioequivalency. Since
the drug is indicated for intravenous use only, the drug is introduced directly
into the blood stream and the bioavailability of the drug is therefore assured.
V. HUMAN SAFETY
The formulations for the 50 mg/ml and the 100 mg/ml drug products
have been evaluated and found chemically and microbiologically equivalent
to the pioneer 100 mg/ml product. Therefore, since the products are both chemically
and microbiologically equivalent and the fact that the products are indicated
for intravenous use only assuring biological equivalence with 100 mg/ml the
pioneer product, the 19-day withdrawal period for the pioneer product has
been assigned to these products. Tissue residue data are not necessary.
VI. AGENCY CONCLUSIONS
The data submitted in support of this new animal drug application comply with
the requirements of 512 of the Act and demonstrate that Oxytetracycline
Injection 50 mg/ml and 100 mg/ml when used under its proposed condition of use
are safe and effective for labeled indications.
Approval of the application poses no increased human risk from exposure to
residues of oxytetracycline because the number of food producing animals
receiving medication will not significantly increase and because the drug is
already regulated at the requested use level.
The prescription (Rx) and over-the-counter (OTC) status is the same as the
pioneer's. Therefore, this product is approved as an over the counter product
as well as a prescription product.
1. Biocyl-50 box label, 500 ml vial
2. Biocyl-50 package insert, 500 ml vial
3. Biocyl-100 box label, 100 ml vial
4. Biocyl-100 box label, 500 ml vial
5. Biocyl-100 package insert, 100 ml vial
6. Agricyl-50 vial label, 500 ml vial
7. Agricyl-50 package insert
8. Agricyl-100 vial label, 100 ml vial
9. Agricyl-100 vial label, 500 ml vial
10. Agricyl-100 package insert
Copies of these labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855